Medical Device Recalls

8,553 medical device recalls from federal enforcement feeds.

Showing 1,301–1,350 of 8,553

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Order Number G12115.

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Tornier, Inc

  Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial,

  Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.

  Class II

• Medical Device Recall · March 5, 2026

  Daavlin Distributing Company

  Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

  Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

  Class II

• Medical Device Recall · March 5, 2026

  Daavlin Distributing Company

  Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

  Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Vue Motion V12. Product Number: 1017979.

  Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL NCompass¿ Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G4

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA, Order Number G576

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Numbe

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 5, 2026

  Cook Incorporated

  COOK MEDICAL Blue Rhino¿ G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-HC-G-NA, Order Num

  Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

  Class II

• Medical Device Recall · March 4, 2026

  Koven Technology, Inc.

  Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product

  Product labeling includes a fetal indication for use that is not cleared under its 510(k).

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Straight Art, Non-Braided; SOFT-VU STR ART 4F X 65CM 035 NB 0SH; Catalog No.: 10731401; Product/UPN No.: H787107314015 (Box), H787107314010 (Pouch); Box Quantity: 5

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 2 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 2 R/O 2CM; Catalog No.: 13709005; Product/UPN No.: H787137090055 (Box), H787137090050 (Pou

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD10 OR Table; System Code: (1) 722022, (2)722033;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Omni Flush, Non-Braided; SOFT-VU OF 4F X 65CM 035 NB 6SH; Catalog No.: 10732301; Product/UPN No.: H787107323015 (Box), H787107323010 (Pouch); Box Quantity: 10 units;

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 NB 10SH; Catalog No.: 10707103; Product/UPN No.: H787107071035 (Box), H787107071030 (Pouch); Box Quantity: 10;

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/15; System Code: 722058;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft -Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 038 NB 0SH; Catalog No.: 10710013; Product/UPN No.: H787107100135 (Box), H787107100130 (Pouch); Box Quantity: 5 pouches;

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 65CM 038 NB 0SH; Catalog No.: 10714011; Product/UPN No.: H787107140115 (Box), H787107140110 (Pouch); Box Quantity: 5 pouches

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  AccuVu Angiographic Catheter, Straight Flush, Non-Braided, With 10 R/O Markers; ACCU-VU STR FL 4F X 100CM 035 NB 6SH 10 R/O 6@1CM 4@5CM; Catalog No.: 13709604; Product/UPN No.: H787137096045 (Box),

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD10C; System Code: 722001;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided; SOFT-VU HH1 4F X 100CM 038 NB 0SH; Catalog No.: 10714040; Product/UPN No.: H787107140405 (Box), H787107140400 (Pouch); Box Quantity: 5 p

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACCU-VU OF 4F X 70CM 035 NB 6SH 21 R/O 1CM; Catalog No.: 13709704; Product/UPN No.: H787137097045 (Box), H787137097040 (P

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-VU PT 4F X 70CM 035 NB 10SH 21 R/O 1CM; Catalog No.: 13709804; Product/UPN No.: H787137098045 (Box), H787137098040 (Pou

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20 OR Table; System Code: 722039;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 100CM 038 NB 0SH; Catalog No.: 10714016; Product/UPN No.: H787107140165 (Box), H787107140160 (Pouch); Box Quantity: 5 pouch

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Berenstein, Non-Braided; SOFT-VU BER 4F X 65CM 038 NB 0SH; Catalog No.: 10714009; Product/UPN No.: H787107140095 (Box), H787107140090 (Pouch); Box Quantity: 5 pouche

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Allura Xper FD20/20; System Code: 722038;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD10F; System Code: 722002;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Cobra (2), Non-Braided; SOFT-VU CB2 4F X 100CM 038 NB 0SH; Catalog No.: 10714018; Product/UPN No.: H787107140185 (Box), H787107140180 (Pouch); Box Quantity: 5 pouche

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD20; System Code: (1) 722006, (2)722012, (3)722028;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1 4F X 80CM 038 NB 0SH; Catalog No.: 10714024; Product/UPN No.: H787107140245 (Box), H787107140240 (Pouch); Box Quanti

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 5 M12; System Code: (1)722227, (2)722231;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 7 M20; System Code: (1)722079, (2)722224, (3)722234, (4)722282 (OUS only);

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Kumpe, Non-Braided; SOFT-VU KMP 4F X 40CM 035 NB 0SH; Catalog No.: 10734301; Product/UPN No.: H787107343015 (Box), H787107343010 (Pouch); Box Quantity: 5 pouches;

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  Angiodynamics, Inc.

  Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided; SOFT-VU CB1 4F X 100CM 038 NB 0SH; Catalog No.: 10714017; Product/UPN No.: H787107140175 (Box), H787107140170 (Pouch); Box Quantity: 5 pouche

  The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II

• Medical Device Recall · March 3, 2026

  PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  ALLURA Xper FD10; System Code: (1) 722003, (2)722010, (3)722026;

  Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

  Class II